Navigating the Indonesian Regulatory Landscape: An Interview with Hussein of Product Registration Indonesia

Teddy: Welcome to The Elendi Files, where we navigate the complexities of the global regulatory landscape of medical products. Our goal is to help make global medical product regulations accessible to everyone—whether you are a manufacturer, intermediary, regulatory specialist, or CEO of a med-tech startup. At ElendiLabs, we’re all about connecting clients with the right regulatory expertise to get products to people faster. Today, I’m thrilled to be joined by Hussein from Indonesia, a firm that helps to navigate the complexities of the Indonesian market. Hussein, could you give us a brief introduction of what Product Registration Indonesia specializes in?

Hussein: Thank you, Teddy, for having me. My name is Hussein and I’m currently the CEO and co-founder at Product Registration Indonesia. We are basically a consulting firm. We help with market entry in the aspect of regulatory affairs for medical devices, supplements, quasi-medicine, herbal standardized medicine, and halal. I have been in the industry for more than 15 years, but we also have partners in the firm totaling more than three decades of combined experience.

Costs and Timelines

Teddy: Let’s dive a bit deeper. What are the costs and timelines like for registering a Class A medical device in Indonesia?

Hussein: The SLA (Service Level Agreement) from the Ministry of Health is 15 working days. During that process, the government can ask for supplemental data, giving you an additional 10 days. After providing those, the government adds another 10 working days for review. Combined, it is around 45 working days. Based on past experiences, our fastest time right now on record is around two and a half to three months for Class A. Bottlenecks occur if manufacturers are not ready with documents, especially regarding the Letter of Authorization (LOA). Indonesia accepts apostilled documents, but from several countries, I prefer using the Indonesian embassy due to language differences. Another bottleneck is the government website, which is prone to downtime.

The Digital Transition

Teddy: Is the application 100% electronic now?

Hussein: Indonesia is transitioning to a 100% online submission. There is no way for a consultancy to submit a paper application anymore. The problem is that the government is not currently 100% prepared for the volume of submissions. We have several techniques to provide our clients access by directly emailing the person in charge at the Ministry of Health.

Market Misconceptions

Teddy: Indonesia is the largest healthcare market in Southeast Asia. What is the single largest misconception international brands have about the market?

Hussein: Many international manufacturers think that the business model that works everywhere else will work in Indonesia. That’s the biggest misconception because Indonesia has 17,000 islands and thousands of languages. There is no "one size fits all" here. Also, registration is just the first part.

"We act as the license holder but do not perform commercial activities. The manufacturer can then appoint as many sub-distributors as they like... If a distributor doesn't perform, it’s easy to disconnect them."

Choosing the Right Partner

Teddy: A foreign manufacturer must appoint a local distributor who holds the marketing authorization. What advice would you give to ensure they choose a partner who won’t "trap" the licenses later on?

Hussein: Indonesia adopts an exclusive distributorship model for regulatory registration. We’ve seen many bad stories where a manufacturer gets locked in with a distributor that doesn’t perform. Our business model offers a middle ground: we act as the license holder but do not perform commercial activities. The manufacturer can then appoint as many sub-distributors as they like—for example, one for Java, one for Sumatra, or one for private vs. reimbursement channels. If a distributor doesn't perform, it’s easy to disconnect them.

CDAKB and Local Content (TKDN)

Teddy: You mentioned the CDAKB (Good Distribution Practice). Is this now a mandatory prerequisite?

Hussein: CDAKB has been mandatory since July 2024. If a company doesn’t have it, currently registered products aren't revoked, but you cannot register a new one. You also cannot be involved in government tenders. Companies are given notice if they aren't fulfilling CDAKB, and they must upload the certification each time they register or enter a tender.

Teddy: There is a term called TKDN (local content requirements) for government tenders. How is this impacting international manufacturers?

Hussein: The government practices what I call "obligatory favoritism." They favor products with higher local content, especially above 40%. If a product is above 40%, a government hospital must choose it over one with less. However, if your product is novel and there is nothing like it in the market, 0% local content is okay. Also, because of the 17,000 islands, not all distributors can reach everywhere; in some remote areas like Papua, lower local content is permissible, but those hospitals are then prone to government audits. Some hospitals are very scared of audits because people can lose their jobs, so they might avoid buying products below 40% altogether.

Halal Requirements

Teddy: What about the evolving halal certification requirements for medical devices?

Hussein: It is not a deal-breaker yet, but your product might face issues during customs because halal is now based on HS codes. Indonesia is 80% to 90% Muslim, so halal is already a big issue. Soon, the government might require a label on non-halal products with a big red square indicating it doesn't fulfill halal requirements. If you have a halal assessment from a recognized body in the US or UK, it can speed up the process through mutual recognition, but it doesn’t mean you get automatic halal status in Indonesia.

International Certifications and SKU Distribution

Teddy: If a manufacturer has CE mark or US FDA approval, can that accelerate the submission?

Hussein: It is supplemental but not mandatory. The mandatory requirement is the Certificate of Free Sale and registration from the country of origin. CE or FDA approval makes registration easier and the Ministry of Health might ask for less data, but all mandatory requirements must still be met.

Teddy: Can one brand have multiple distributors for the same SKU?

Hussein: No, that’s not possible. One brand can have multiple distributors, but for different SKUs. For product one, you have distributor A; for product two, you have distributor B. But for product one, you cannot have distributors A, B, and C.

Teddy: I understand the IDAK has replaced the old IPAK licenses. How is this impacting manufacturers?

Hussein: We’ve helped clients migrate, and it is a very straightforward process taking about 15 days. While the old license was indefinite, the new IDAK is valid for five years, but it shouldn't be a major concern as the process is fast and smooth.

Teddy: Hussein, thank you for these "boots on the ground" perspectives. We will be featuring Product Registration Indonesia as a vetted specialist firm on the ElendiLabs platform.